510(k) K893643

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER by Novametrix Medical Systems, Inc. — Product Code DQA

K893643 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER". The FDA issued a decision of Substantially Equivalent on October 26, 1989. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.